Costs for administrative activities under the GenTG

Fees may be charged for official actions under the Genetic Engineering Act. As far as these involve activities by federal authorities, the costs are governed by the BGenTGKostV (Federal Act on Genetic Engineering). For example, Section 2, Paragraph 1 of the BGenTGKostV stipulates costs for permits – typically release permits or marketing permits – in the range of €2,500.00 to €15,000.00 (releases) and €5,000.00 to €30,000.00 (marketing).
As far as official acts of the states based on the Genetic Engineering Act are concerned, such as notifications and registrations for genetic engineering facilities, the states have largely issued their own fee schedules. In North Rhine-Westphalia, for example, the General Administrative Fee Schedule applies as of April 2016. This schedule lists the fees for matters related to genetic engineering law under tariff item 27. A distinction is made between fees that the licensing authority may charge (27.1.1 – 27.1.2) and fees that may arise for testing, monitoring, and issuing orders (27.1.3 – 27.1.11), as well as for official acts pursuant to the ordinances implementing the Genetic Engineering Act (27.2.1 – 27.2.6).
Within the scope of the approval decisions, the fee for reviewing a notification for the construction and operation of genetic engineering facilities at safety level 1, as well as for significant changes to genetic engineering facilities at safety level 1, is between €100.00 and €3,500.00. As a rule, the fees are set at the lower end, i.e. around €800.00. For reviewing a notification for the construction and operation of genetic engineering facilities at safety level 2, or for significant changes to genetic engineering facilities at safety level 2, the fee range is €100.00 to €4,500.00. The starting fee here would be approximately €1,000.00 to €1,300.00. The fees are lower when it comes to reviewing a notification for further genetic engineering work at safety level 2 (Section 9 (2) Sentence 1 GenTG). In this case, the fee range is €100.00 to €250.00. Subsequent orders still cost between €75.00 and €250.00.

This publication can also be found on the website of the law firm Dr. Kauch .